An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years
A Retrospective Study to Characterize Patients With HER2-positive Metastatic or Locally Advanced Breast Cancer, Treated by Herceptin® as 1st Line-therapy and Without Progression for at Least 3 Years Followed by a 1-year Prospective Study for Patients Still Alive
1 other identifier
observational
160
1 country
78
Brief Summary
This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2011
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 28, 2011
CompletedFirst Submitted
Initial submission to the registry
August 18, 2011
CompletedFirst Posted
Study publicly available on registry
November 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2012
CompletedResults Posted
Study results publicly available
February 24, 2016
CompletedAugust 16, 2017
June 1, 2017
1.6 years
August 18, 2011
January 27, 2016
July 7, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Tumor Hormone Receptor Status of Participants Without Progression
The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival.
Up to 3 years
Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment
Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported
Up to 3 years
Secondary Outcomes (7)
Progression-free Survival
Up to 12 years
Time to Progression
Up to 12 years
Overall Survival
Up to 12 years
Dosage Schedule of Herceptin Treatment
Up to 12 years
Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment
Up to 12 years
- +2 more secondary outcomes
Study Arms (1)
Trastuzumab
Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Interventions
Eligibility Criteria
Patients with HER2-positive metastatic breast cancer or locally advanced breast cancer whose systemic treatment included Herceptin as 1st line therapy, and who were without progression for at least 3 years after beginning Herceptin
You may qualify if:
- Female patients, \>/= 18 years of age
- HER2-positive metastatic breast cancer or locally advanced breast cancer
- Systemic treatment included Herceptin as 1st line therapy
- Without progression for at least 3 years after the beginning of Herceptin treatment
You may not qualify if:
- Disease progression \<3 years after beginning 1st-line therapy with Herceptin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Clinique Du Docteur Calabet; Cromg
Agen, 47000, France
C.H. Du Pays D'aix En Provence Service du Dr Blanc
Aix-en-Provence, 13616, France
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
Aix-en-Provence, 13617, France
Chd Castelluccio; Oncologie
Ajaccio, 20176, France
Clinique De L Europe; Pmsi
Amiens, 80090, France
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, 80090, France
HOP Prive Arras Les Bonnettes; Chimiotherapie
Arras, 62012, France
Hopital Europeen La Roseraie;Radiotherapie
Aubervilliers, 93308, France
Polyclinique Sainte Marguerite; Chimiotherapie
Auxerre, 89000, France
Clinique Champeau Mediterranee; Radiotherapie Oncologie
Béziers, 34535, France
Hopital Saint Andre; Oncologie 2
Bordeaux, 33075, France
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, 33077, France
Centre Hospitalier Fleyriat; Oncologie/Hematologie
Bourg-en-Bresse, 01012, France
Hopital Augustin Morvan; Hopital De Jour
Brest, 29609, France
Ch De Brive La Gaillarde; Radiotherapie Oncologie
Brive-la-Gaillarde, 19312, France
Centre Francois Baclesse; Comite Sein
Caen, 14076, France
Ch Antoine Gayraud; Oncologie
Carcassonne, 11890, France
Clinique Montreal; Chimiotherapie
Carcassonne, France
Ch William Morey; Medecine 1
Chalon-sur-Saône, 71321, France
Centre Jean Perrin; Hopital De Jour
Clermont-Ferrand, 63011, France
Pole Sante Republique;Oncologie Hematologie
Clermont-Ferrand, 63050, France
Ch De Dax; Radiotherapie Oncologie
Dax, 40107, France
Centre Leonard De Vinci;Chimiotherapie
Dechy, 59187, France
Centre Georges Francois Leclerc; Oncologie 3
Dijon, 21079, France
Hopital Prive Drome Ardeche; Chir 2A 2B
Guilherand-Granges, 07500, France
Clinique de L' Esperance; Oncologie
Hyères, 83400, France
Polyclinique de Blois; Chimiotherapie Ambulatoire
La Chaussée-Saint-Victor, 41260, France
CH Dptal Les Oudairies; Hematologie Oncologie
La Roche-sur-Yon, 85925, France
Hopital Albert Michallon; Oncologie
La Tronche, 38700, France
Polyclinique Du Bois; Centre Bourgogne
Lille, 59000, France
Polyclinique Du Bois; Oncologie
Lille, 59003, France
Ch De Longjumeau; Hopital De Jour Et Semaine
Longjumeau, 91161, France
Clinique Des 4 Pavillons; Chimiotherapie
Lormont, 33310, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373, France
Polyclinique Du Beaujolais; Chimiotherapie
Lyon, 69400, France
Hopital Edouard Herriot; Pavillon F Rhumatologie
Lyon, 69437, France
Hôpital Saint Joseph; Oncologie Medicale
Marseille, 13285, France
Polyclinique Du Val De Saone; Chimiotherapie
Mâcon, 71000, France
Ch De Montelimar; Radiotherapie
Montélimar, 26216, France
Clinique Clementville; Hopital De Jour
Montpellier, 34070, France
Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
Montpellier, 34967, France
Centre Azureen De Cancerologie; Cons externes
Mougins, 06250, France
Hopital Emile Muller; Oncologie Radiotherapie
Mulhouse, 68070, France
Centre D'Oncologie de Gentilly; Oncology
Nancy, 54100, France
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
Nancy, 54100, France
Clinique Des Genets; Radiotherapie
Narbonne, 11108, France
Clinique Henry Hartmann; Oncologie
Neuilly-sur-Seine, 92200, France
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, 06189, France
Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie
Nîmes, 30029, France
Polyclinique Kenval ; Radiotherapie Oncologie
Nîmes, 30900, France
Clinique sainte marie; chimiotherapie ambulatoire
Osny, 95520, France
Hopital Saint Louis; Oncologie Medicale
Paris, 75475, France
Hopital Des Diaconesses; Hopital De Jour
Paris, 75571, France
Ch Pitie Salpetriere; Oncologie Medicale
Paris, 75651, France
HOPITAL TENON; Cancerologie Medicale
Paris, 75970, France
Clinique Francheville; Radiotherapie
Périgueux, 24000, France
Ch Lyon Sud; Hemato Secteur Jules Courmont
Pierre-Bénite, 69495, France
Ch Lyon Sud; Onco Secteur Jules Courmont
Pierre-Bénite, 69495, France
Ch De Pithiviers; Consult Externes
Pithiviers, 45307, France
Institut Jean Godinot; Pavillon Rubis
Reims, 51056, France
Polyclinique De Courlancy; Chimiotherapie Ambulatoire
Reims, 51057, France
Centre Eugene Marquis; Unite Huguenin
Rennes, 35042, France
Clinique Saint Hilaire; Sce Chimiotherapie
Rouen, 76044, France
Chp Saint Gregoire; Cancerologie Radiotherapie
Saint-Grégoire, 35768, France
Ico Rene Gauducheau; Oncologie
Saint-Herblain, 44805, France
Clinique de L'Union; Oncologie
Saint-Jean, 31240, France
Centre Radiotherapie Etienne Dolet
Saint-Nazaire, 44600, France
Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0
Saint-Priest-en-Jarez, 42271, France
Ch De Saint Quentin; Medecine B10
Saint-Quentin, 02321, France
CH De Senlis; Medecine 2
Senlis, 60309, France
Ch De Soissons; Medecine Ambulatoire
Soissons, 02209, France
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059, France
Clinique Pasteur; Oncologie Medicale
Toulouse, 31076, France
Chevelle Christian; Centre De Radiotherapie
Toulouse, France
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, 54511, France
Hopital Saint Nicolas; Pneumologie
Verdun, 55107, France
Institut Gustave Roussy; Comite 5
Villejuif, 94805, France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, 94805, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2011
First Posted
November 29, 2011
Study Start
March 28, 2011
Primary Completion
November 16, 2012
Study Completion
November 16, 2012
Last Updated
August 16, 2017
Results First Posted
February 24, 2016
Record last verified: 2017-06